# K223210: ClotTriever XL Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Inari Medical, Inc.
- Decided: Apr 27, 2023 after 192 days
- Product code: QEW (Peripheral Mechanical Thrombectomy With Aspiration)
- Device class: 2
- Regulation: 21 CFR 870.5150
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 17 generations back to K901627 (1990). 26 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 28 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212632: ClotTriever Thrombectomy System, Inari Medical, Inc. (2021) Summary page 4.

## Most influential descendants
- K242557: ClotTriever XL Catheter (41-102) (2024), 0 descendants of its own

## Recalls of this device
- Jul 19, 2024 · Class I · Z-2587-2024: Thrombectomy system catheter instructions for use updated to reduce adverse events due to the following circumstances: 1) Fibrous, firmly adherent, calcified material, or suspected tumor thrombus over

## Indications for use
The ClotTriever Thrombectomy System is indicated for: • The non-surgical removal of thrombi and emboli from blood vessels. • Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. The ClotTriever Thrombectomy System is intended for use in the peripheral vasculature including deep vein thrombosis (DVT).

Source page: https://510kreport.com/device/K223210
Methodology: https://510kreport.com/methodology